Kornimate/medical-research-clean huggingface dataset:
effect of intraoperative muscle relaxation depth on postoperative sore throat and hoarseness after general anesthesia

Conditions: Sore Throat

Summary: investigators assess and compare postoperative sore throat and hoarseness in the group maintaining moderate relaxation and deep relaxation during operation.

in this sturdy, the deep block is applied when the surgeon requests for deep muscle relaxation to improve surgical field condition in the surgery such as laparotomy known that the deep block is helpful and in the other surgeries, the moderate block is maintained. the investigators assess the postoperative sore throat and hoarseness and compare the effect of muscle relaxation depth in the deep block group and moderate block group in terms of the incidence and severity of postoperative sore throat and hoarseness.

Eligibility criteria:
inclusion criteria: * requirement for mechanical ventilation under general anesthesia exclusion criteria: * hoarseness and sore throat existed before surgery * upper respiratory infection * known or predicted difficult airway * liver, renal disease * requirement of postoperative ventilator care * the operation within 2hrs * laparoscopic surgery * other positions except supine during surgery

Keywords: muscle relaxant
pre-meal consumption of whey in gestational diabetes mellitus from diagnosis to delivery

Conditions: Gestational Diabetes

Summary: the main objective of the study is to investigate the metabolic effects of whey protein (whey protein isolate, wpi, (lacprodan® iso.water. from arla foods ingredients) compared with placebo when consumed by women with gestational diabetes mellitus (gdm) from diagnosis (around gestational week 28) to delivery. any changes in substrate metabolism and energy expenditure using indirect calorimetry will also be investigated. differences in hunger and satiety parameters as well as blood pressure and gestational weight gain will also be assessed. furthermore, analysis on the glucose response when the women consume the intervention (whey or placebo) at home in their own environment 30 minutes before breakfast at time of diagnosis (earliest week 28) and week 36 (four days following each time point) will be made. the women will be monitored with continuous glucose monitors, activity monitors and all meals will be provided for two days following the study days in the laboratory. at delivery cord blood will be sampled for analysis on metabolic parameters and investigations on epigenetics/dna methylations. complications to the delivery, neonatal outcomes, anthropometrics of the child will also be assessed. breast milk composition will also be analyzed.


Eligibility criteria:
inclusion criteria: * gdm (ogtt level of blood glucose ≥ 9 mmol/l) * normal blood pressure * age \> 18 years exclusion criteria: * special dietary regimes \> 1 month at time of inclusion e.g. ketogenic diet * daily intake of protein supplements * milk allergy or phenylketonuria * medication with effect on glucose metabolism e.g. steroids * do not speak or understand danish * twin pregnancy * pcos * pi finds the patient unfit (like mental illness, too nervous or other) * severe chronic illness * severe nausea/vomiting * non-breakfast eaters * celiac disease the initiation of insulin treatment during the trial will not lead to exclusion from the trial.
morphine for the treatment of pain in patients with breast cancer

Conditions: Pain

Summary: rationale: morphine helps to relieve the pain associated with cancer surgery. giving morphine in different ways may offer more pain relief. purpose: this randomized clinical trial is studying how well morphine injected directly into the underarm area works compared with morphine injected into the back of the shoulder in treating pain in patients who have breast cancer and who are undergoing axillary lymph node dissection.

objectives: i. determine whether morphine injected at the site of surgery can control pain from surgery. outline: this is a prospective, double blind, randomized study. patients are randomized into 3 groups with 6 patients in each group. group 1 receives morphine diluted in normal saline (ns), which is administered in the axillary region at the completion of surgery before surgical closure. the area is flooded and the solution is allowed to remain in the wound for 5 minutes. group 2 (control group) receives ns only, administered in the same fashion as group 1. group 3 receives morphine subcutaneously in the deltoid area, ipsilateral to the site of surgery, at the beginning of wound closure. postoperatively, patients self-administer iv fentanyl analgesia through a patient controlled analgesia pump. comparisons of daily iv fentanyl utilization is done among the three groups. quality of pain is assessed via visual analog pain scores four times a day at 2, 4, 6, and 24 hours postoperatively. projected accrual: a total of 18 patients will be accrued over a period of 2 years.

Eligibility criteria:
disease characteristics: patients with breast cancer who are scheduled to undergo axillary node dissection patient characteristics: see general eligibility criteria prior concurrent therapy: no oral-equivalent doses of morphine greater than 10 mg a day -- patient characteristics-- age: not specified sex: not specified other: not allergic to morphine

Keywords: pain
circulating tumour dna (ctdna) as a prognostic and predictive marker in colorectal cancer - a pilot study

Conditions: Colorectal Cancer

Summary: in clinical practice, there are currently no biomarkers that can guide colorectal cancer treatment in the primary and curative setting. improved biomarker-based adjuvant treatments would be of greatest value in order to reduce the risk of relapse. there are reasons to believe that measurements of circulating tumor dna (ctdna) in plasma could be used to monitor minimal residual disease after surgery. to address this question, a pilot study was conducted with the purpose to demonstrate the feasibility to perform prospective profiling of ctdna in a cohort of patients with colorectal cancer stage i-iii using the already created nordic infrastructure for clinical research built up for the alascca trial. if the pilot study proves successful, a large randomised controlled nordic multicenter study is planned where patients with positive ctdna 4-6 weeks after radical surgery will be randomised to chemotherapy and/or a biologic agent.


Eligibility criteria:
inclusion criteria: * colon or rectal cancer tumor stage i-iii planned for radical surgery * clean colonoscopy or computed tomography (ct) colon within 3 months preoperatively or postoperatively but before randomization * patient able to understand and sign written informed consent exclusion criteria: * distant metastases * other cancers (excluding colorectal cancer or other skin cancer than melanoma) within 3 years from screening * significant medical illness that would interfere with study participation * pregnancy or breastfeeding females * current participation in another clinical trial that will be in conflict with the present study * patients who are unlikely to comply with the protocol (e.g. uncooperative attitude, inability to return for subsequent visits) and/or otherwise considered by the investigator to be unlikely to complete the study

Keywords: predictive marker prognostic marker ctdna colon cancer rectal cancer
the effect of the severity of covid-19 disease on the incidence of acute renal failure in icu

Conditions: COVID19; Acute Renal Failure

Summary: aim of the study is to determinate the frequency of acute renal failure in covid-19 patients, its relationship with the severity of covid-19 disease in icu, and the ability to take precautions against these factors.


Eligibility criteria:
inclusion criteria: patients hospitalized in the intensive care unit diagnosed with covid-19 will include in the study. exclusion criteria: there is no exclusion criteria

Keywords: covid19 acute renal failure
the significance of blood-tryptase and c-kit mutation in insect venom immunotherapy

Conditions: Hypersensitivity, Immediate; Insect Bites and Stings; Mastocytosis

Summary: the investigators wish to evaluate the association between tryptase values as well as c-kit mutation and adverse effects in the course of immunotherapy. the investigators also intend to assess the effect of immunotherapy on tryptase levels.

according to the presently available reports there is an association between systemic allergic responses to hymenoptera venom and elevated tryptase levels or c-kit mutation. the presence of these findings may imply the existence of mast cell activation syndrome or mastocytosis. therefore, baseline tryptase evaluation has become standard evaluation in patients with systemic responses. meir medical center is the only hospital in israel in which tryptase can be measured. consequently, the meir clinic has accumulated considerable data with regards to tryptase levels in subjects with allergy to hymenoptera venom. the investigators wish to evaluate the association between tryptase values as well as c-kit mutation and adverse effects in the course of immunotherapy. the investigators also intend to assess the effect of immunotherapy on tryptase levels.

Eligibility criteria:
inclusion criteria: * history of systemic response to hymenoptera sting. * subject under current or planned venom immunotherapy. exclusion criteria: * previously diagnosed mast cell disorder
empowering patients on choices for renal replacement therapy (aim 1)

Conditions: Chronic Kidney Disease

Summary: the epoch-rrt study seeks to fill knowledge gaps by gaining more understanding of chronic kidney disease (ckd) patients' priorities; assessing the comparative benefits of hemodialysis (hd) versus peritoneal dialysis (pd), with respect to these priorities; and providing tailored information to assist patients with identifying the best dialysis modality fit for their own unique circumstances and perspectives. the outcomes most relevant to patients ("patient-centered") extend beyond those traditionally assessed in clinical research, with the relative importance varying across patient groups. a tailored decision aid based on these findings can improve patient decision-making processes regarding choice of dialysis modality.

empowering patients on choices for renal replacement therapy (epoch-rrt)study seeks to identify factors that matter the most to patients with kidney disease and study how they are impacted by different types of dialysis. the inclusion of patients, caregivers, and patient advocacy organizations as research partners will assure that the study addresses questions of greatest relevance to patients facing the need for dialysis. aim one of epoch-rrt identifies outcomes that are most important to different groups of advanced ckd and dialysis patients through qualitative methods applied for conducting in-depth interviews.

Eligibility criteria:
inclusion criteria: * individuals 18 years of age or older. * individuals with advanced chronic kidney disease or on dialysis (in-center, hemodialysis, or peritoneal dialysis) for at least three months. exclusion criteria: * individuals under 18 years of age. * individuals unable to provide informed consent. * individuals who do not have chronic kidney disease.

Keywords: chronic kidney disease hemodialysis peritoneal dialysis
mesenchymal stem cell in patients with acute severe respiratory failure

Conditions: Respiratory Distress Syndrome, Adult

Summary: although the advent of advanced medical support for respiratory failure, the mortality rate of acute severe respiratory failure is still high and the life quality is frequently compromised from pulmonary fibrosis. the investigators hypothesize that the treatment using mesenchymal stem cell can be beneficial in patients with respiratory failure. the present study is a pilot study evaluating the efficacy and safety of mesenchymal stem cell treatment in patients with respiratory failure.

although the advent of advanced medical support for respiratory failure, the mortality rate of acute severe respiratory failure is still reported to be more than 40%. the respiratory distress syndrome may develop in all ages resulting in progressive pulmonary fibrosis. a number of survivors from respiratory failure suffer from the sequelas of pulmonary fibrosis. however, the treatments of respiratory failure are limited to the correction of baseline disease, cardiopulmonary support, and conservative management to minimize the lung injury. there has not been any effective and specific treatment for respirator distress nor medicine to reduce mortality. there have been reports of mesenchymal stem cell experimental animals with chronic obstructive pulmonary disease, interstitial lung disease, and sepsis. in addition, the mesenchymal stem cell treatment showed beneficial effect in bleomycin endotoxin induced lung injury. authors hypothesize that the mesenchymal stem cell treatment in patients with respiratory failure will show efficacy. we would conduct the present pilot study to evaluate the efficacy and safety in patients with respiratory failure and intend to suggest an additional alternative treatment option for those without additional treatment option.

Eligibility criteria:
inclusion criteria: * ventilator care from respiratory failure * ventilator care for 7 or more days * at least one of the followings 1. pao2/fio2 = 200 or less when peep 5 cmh2o or more. 2. paco2 = 50 mmhg or more when plateau pressure of 30 cmh2o or more. 3. ph = 7.25 or less when plateau pressure of 30 cmh2o or more. 4. no other treatment option except for lung transplantation and not candidate for recipient (organ failure, comorbid infection, economy,...) 5. ventilatory care with weaning failure 3 times or more 6. ventilator care requiring 7 days or more from the first self respiration to weaning of ventilator. * peep, positive endexpiratory pressure exclusion criteria: * severe aplastic anemia * malignant hematologic disorder or history of stem cell treatment. * currently uncontrolled malignancy or history of solid cancer within 2 years * hiv infection * expected life \< 3 months from other cause than the respiratory failure * pregnancy or breast feeding * expected hypersensitivity for study drug
vibration exercise for crohn's to observe response

Conditions: Crohn's Disease

Summary: background: crohn's disease (cd) is a long-term inflammatory condition of the digestive system. people with cd often have unpredictable and debilitating symptoms, including abdominal pain, diarrhoea and fatigue. in addition, they require long-term treatment with frequent negative effects and often need surgery and hospitalisations. therefore, people with cd report a lower health-related quality of life (hrqol) compared with other people. doctors are constantly trying to find new treatments to improve hrqol and control symptoms and whole body vibration exercise could be a potential treatment. exercise might be a simple, safe, and low-cost intervention for improving hrqol in people with cd. this is because it has the potential to improve several aspects of physical, mental and social well-being simultaneously. adults with cd have been shown to be less active than the general population and do not meet the recommended daily physical activity guidelines. one barrier to exercise is lack of time, however whole-body vibration exercise (where you stand and squat on a vibrating plate) can be done over a much shorter duration and at a lower intensity to gain potentially similar or at times greater benefits. more research is needed to understand the effects, both positive and negative of vibration exercise in people with cd. aim: this study begins to understand whether undertaking a supervised 6-week vibration exercise programme for adults with mild to moderately active crohn's disease improves hrqol and other symptoms such as fatigue.


Eligibility criteria:
inclusion criteria: * aged over 18-65 years old * clinical diagnosis of cd for at least 4 weeks before randomization * mild to moderate active cd (150-220 cdai) * stable medication for at least 4 weeks before randomization * able to provide written consent, complete the study questionnaires and travel to the research centre for study assessment visits and exercise sessions * be doing less than 60 minutes of purposeful exercise per week exclusion criteria: * over 65 years old severe or uncontrolled medical conditions that make it undesirable for the patient to participate * coexistent serious autoimmune disease such as rheumatoid arthritis or systemic sclerosis * planned major surgery within the first 3 months after randomization * are pregnant, or are planning pregnancy within the first 3 months after randomization * poor tolerability to venepuncture or lack of adequate venous access for required blood sampling * current participation in \>60 min/week of purposeful exercise, such as jogging or cycling * participation in another clinical trial for which concurrent participation is deemed inappropriate * any orthopaedic implants (hip, knee, spine)
tdcs for treatment resistant obsessive compulsive disorder

Conditions: Obsessive-Compulsive Disorder

Summary: it's a multicentric, randomized, controlled study concerning 100 patients with treatment-resistant obsessive compulsive disorders (ocd). the aim of this study is to evaluate the effect of transcranial direct current stimulation (tdcs) on ocd patients.


Eligibility criteria:
inclusion criteria: * meets criteria for obsessive compulsive disorder according to diagnostic and statistical manual (dsm iv) with a "good insight" (babs) * no current depressive and suicidal risks * no epileptic pathology * age: participants will be both males and females, 18-70 years of age included. * chronic obsessive compulsive disorder ( total y-bocs\>20 or y-bocs one subscale \> 15) * obsessive compulsive disorder resistant to pharmacology treatment : 1. at least 2 antidepressants (irs type) (\> 12 weeks) 2. cognitive and comportment therapy since at least one year * treatment stability (antidepressants) for more than 12 weeks without significant improvement. * affiliation to a social security system (recipient or assignee), * signed written inform consent form exclusion criteria: * female subject who is pregnant, or of child-bearing age, sexually active and not using reliable contraception or who is nursing, * patient under curators * patient hospitalized under duress * meets another diagnosis of axe 1 of dsm-iv * current depressive or suicidal risks * patient with any form of metal in the cranium, a pacemaker, skull defects, or skin lesions to the scalp (cuts, abrasions, rash) * epileptic patient * patient with a medical history of cranial trauma * patient unable to give his or hers informed consent

Keywords: ocd tdcs
the impact of early feeding after radical cystectomy for bladder cancer

Conditions: Bladder Cancer; Complications

Summary: complications after radical cystectomy for bladder cancer range from 30-40%, many of which are related to bowel function. patients usually wait to eat until return of bowel function, although there is evidence that after primary intestinal or colonic surgery, patients may take food ad lib immediately, and that this is is associated with lower complication rate and shorter length of stay. the investigators hypothesize that early access to oral enteral nutrition (food at will) after cystectomy and urinary diversion will reduce the complication rate both in-hospital and within 90 days after hospital discharge.

subjects preparing to undergo radical cystectomy and urinary diversion for bladder cancer that provide informed consent will be randomized into 1 of 2 study arms. the experimental arm will be offered clear liquid diet 24 hours after extubation and advanced to regular diet 24 hours later if clear liquids are well tolerated. the standard/control arm will receive a clear liquid diet at the time of return of bowel function, determined by significant flatus or bowel movements. information related to time to return of bowel function, frequency of nausea/vomiting, hospital complications and length of stay will be recorded. patients will be followed with phone calls and chart reviews at 30, 60 and 90 days following surgery. additional hospital admissions and/or complications will be determined with those phone calls.

Eligibility criteria:
inclusion criteria: * age \>=18 * bladder cancer * elect radical cystectomy and urinary diversion as treatment * able to provide informed consent exclusion criteria: * radical cystectomy for reason other than bladder cancer

Keywords: feeding complications radical cystectomy
effects of blastocyst stage compared with cleavage stage embryo transfer in women below 39 years

Conditions: Infertility

Summary: single center randomized study including 388 women aged less than 39 years, performing in vitro fertilization, to determine if blastocyst stage (day 5 to 6) embryo transfer (ets) improves implantation and pregnancy rate compared with cleavage stage (day 2 to 3) ets.

embryos from in vitro fertilization are routinely transferred into the woman's uterus at cleavage stage (day 2 to 3) or at blastocyst stage (day 5 to 6). the rational of blastocyst stage transfer is that blastocyst stage is the most biologically correct stage for embryos to be in the uterus, and longer culture in the laboratory may give the possibility to reduce the number of genetically abnormal embryos. the investigators design a single center randomized trial, including 388 women aged less than 39 years, performing in vitro fertilization, to confront blastocyst stage embryo transfers (ets) and cleavage stage ets. each patient is randomized with a non blind randomization, based on a computer model, on the first day after fertilization. the primary outcomes are implantation and pregnancy rate. the secondary outcome is to verify if blastocyst embryo transfer leads to a higher multiple-pregnancy rate. an interim analysis takes place at one third of the population. follow up is of 4 weeks for implantation rate, and covers 8 weeks regarding pregnancy rate.

Eligibility criteria:
inclusion criteria: * female patients undergoing ivf procedures * age less than 39 years exclusion criteria: * less than 4 fertilized eggs in day 1 after ivf